Regulatory and pharmaceutical consulting services for the life sciences industry through the lifecycle of their products

AxeRegel regulatory consulting services

Discover all our services

Regulatory Affairs comprise several activities ranging from the preparation of a Marketing Authorization (MA) application for a medicinal product, the registration and maintenance of the MA through, namely, MA variations, to the validation of the packaging materials and product information (SmPC, package leaflet...).

We are at your side to help you find the solution to your needs.

Would you like to delegate part of your vigilance obligations or do you need occasional support for a specific task? Do you need a one-off expert opinion or do you need to outsource completely the handling of your pharmacovigilance cases, your literature review or the drafting of a periodic safety report?

We offer you a scientific expertise adapted to your needs and projects.

Would you like to be accompanied on specific missions or do you need to completely outsource your medical information service?

Our team is attentive to the needs of patients and health professionals in order to provide them with a high-quality response within the guidelines of good practice.

Quality Assurance concerns all the measures taken to ensure that a product or a service meets its quality requirements. Quality Assurance is crucial to pharmaceutical companies.

AxeRegel can offer you flexible and tailored solutions to the challenges you face.

Do you want to open an exploitant pharmaceutical company or to learn about the exploitant status in France?

Do you have promotional documents to review, product quality reviews to carry out or do you need a Qualified Person for batch release?

You no longer need to hesitate, we can provide you with the support and expertise you need.

AxeRegel publishes a weekly newsletter. Our newsletter covers the most interesting regulatory news in France and in the EU regarding medicines.

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